About this trial

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant.

Heart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated.

HVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included.

Neurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.

Eligibility criteria

Qualifiers

Severe aortic valve stenosis

Indication for transcatheter valve therapy according to current guideline recommendations and/or Heart-Team consensus

Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German

Age ≥18 years

Disqualifiers

Known pregnancy at the time of study inclusion

Life expectancy <1 year due to non-cardiac disease

Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack [TIA], migraine, epilepsy) with acute symptoms that may interfere with data collection

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 3 trial groups

Locations

This trial has no locations

Sponsors and collaborators

Heart and Brain Research Group, Germany

Lead sponsor

University of Giessen

Collaborator

University Hospital Giessen and Marburg

Collaborator

Kerckhoff Klinik

Collaborator